Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

NKB 2023-07-03

CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement

Applicant CarboFix Orthopedics , Ltd.

K-Number K231280

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LYR 2023-07-03

Premier HpSA Flex (619096)

Applicant Meridian Bioscience, Inc.

K-Number K230901

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QBD 2023-07-03

CLEARinse CTS Specimen Collection and Transport System

Applicant Aardvark Medical, Inc.

K-Number K221664

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QIH 2023-07-03

Axial3D Insight

Applicant Axial Medical Printing Limited

K-Number K222745

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EIH 2023-07-03

Dental Lithium Disilicate Glass-Ceramic

Applicant Fuzhou Rick Brown Biomaterials Co., Ltd.

K-Number K230487

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QEY 2023-07-03

BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter

Applicant Thrombolex, Inc.

K-Number K231653

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FXX 2023-07-03

Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )

Applicant Cardinalhealth

K-Number K230569

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DZE 2023-07-01

NB Implant System

Applicant Arum Dentistry Co., Ltd.

K-Number K230725

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OMC 2023-06-30

REMI Remote EEG Monitoring System

Applicant Epitel, Inc.

K-Number K230933

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CAW 2023-06-30

Inogen Rove 6

Applicant Inogen, Inc.

K-Number K230052

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FCG 2023-06-30

ClearTip

Applicant Finemedix Co., Ltd.

K-Number K231267

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DQY 2023-06-30

5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter

Applicant Medtronic Vascular

K-Number K230156

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